Full Text DC-92-06

DEVELOPMENT OF A MODEL SYSTEM FOR IDENTIFYING NEONATAL HEARING
IMPAIRMENT

NIH GUIDE, Volume 21, Number 19, May 22, 1992

RFA:  DC-92-06

P.T. 34

Keywords: 
  Disease Model 
  Communicative Disorders, Hearing 
  Diagnosis, Medical 


National Institute on Deafness and Other Communication Disorders

Letter of Intent Receipt Date:  July 31, 1992
Application Receipt Date:  August 21, 1992

PURPOSE

The National Institute on Deafness and Other Communication Disorders
(NIDCD) invites applications for assistance awards to support
cooperative multi-center (consortium) studies of the sensitivity,
specificity, and predictive efficiency of methods to identify neonatal
(birth to three months) hearing impairment.  The major purpose of this
Request for Applications (RFA) is to increase, through consortium
arrangements, the extent and depth of research leading to the
development of timely and efficient methods to identify neonatal
hearing impairment.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Development of a Model System for Identifying Neonatal Hearing
Impairment, is related to the priority area of maternal and infant
health.  Potential applicants may obtain a copy of "Healthy People
2000" (Full Report:  Stock No. 017-001-11474-0) or "Healthy People
2000" (Summary Report:  Stock No. 017-001-11473-1) through the
Superintendent of Documents, Government Printing Office, Washington, DC
20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Any of the following organizations are eligible to apply:  foreign and
domestic non-profit and for-profit organizations and institutions,
State and local governments and their agencies, and authorized Federal
agencies.

MECHANISM OF SUPPORT

The support mechanism for this consortium project will be a cooperative
clinical research grant (R10).  This RFA is a one-time solicitation.
Funding in response to this RFA is dependent upon the receipt of
applications of high scientific merit.  The earliest start date for the
initial awards will be April 1, 1993.

FUNDS AVAILABLE

Awards will be made for project periods of five years.  Up to $5
million total (direct plus indirect) costs is available for the entire
project period of five years, or about $1 million per year total for
all awards.  The NIDCD anticipates making one or two awards, but the
specific amount and number of awards will depend on the merit and scope
of the applications received.  Budget increments after the first year
will be limited to approved programmatic changes and necessary
cost-of-living increases.  Although this project is provided for in the
financial plans of the NIDCD, the award of grants pursuant to the RFA
is contingent on the availability of funds appropriated for fiscal year
1993.

RESEARCH OBJECTIVES

Background

The average age at which profound hearing loss is first detected in
this country is about 2.5 - 3 years, long after the period considered
critical for speech and language development.  Lesser degrees of
hearing loss may go undetected even longer.  This delay can exacerbate
the developmental consequences of early-onset hearing impairment and
add to the difficulty of later habilitation.  Moreover, delayed
identification and intervention may impair the hearing-impaired
person's ability to adapt to life in a hearing world and/or prepare for
life in the hearing-impaired community.  The health care of children
may be compromised by their inability to communicate adequately, and
their educational progress may be slowed by language impairment
secondary to the hearing loss.

Clinicians, well aware of these issues, have approached infant hearing
screening with a number of different test methods over the years:
cardiac response audiometry; respiration audiometry; alteration of
sucking patterns, movement, or startle in response to auditory stimuli;
measurement of acoustic reflexes; and more recently, auditory brain
stem response (ABR) audiometry.  Each is effective in its own way, but
technical or interpretive limitations have impeded widespread
application.  Moreover, these approaches vary widely in their
sensitivity, specificity, and predictive efficiency in identifying
hearing impairment.

Unlike methods used to screen for other abnormal conditions in the
neonatal period (e.g., phenylketonuria, cystic fibrosis), auditory
screening methods often require costly equipment and trained observers,
and are relatively time consuming.  When factors such as prematurity or
central nervous system disorders co-exist, the interpretation of test
results becomes even more complex and predictive error more likely.

Today, most neonatal screening programs are focused on infants who
satisfy one or more of a number of criteria for inclusion in a "high-
risk registry."  The preferred screening method has come to be ABR,
combined with audiologic follow-up for those infants who fail the
screening protocols.  Despite the relatively good predictive efficiency
of ABR, its cost, time requirements, and technical difficulties have
discouraged the general application of this method in screening the far
larger neonate population not meeting high-risk registry criteria.

Recently, the attention of researchers and clinicians has turned to
another technique as a candidate for a fast, inexpensive, non-invasive
means of screening the hearing of infants.  Otoacoustic emissions
(OAEs), which are low amplitude tones that can be measured in the
external ear canal, are thought to be the product of cochlear hair cell
activity.  The emissions may arise spontaneously or be evoked either in
isolation or as the distortion products of auditory stimuli presented
to the ear.  In general, OAEs can be detected and measured only when
cochlear function is normal (although middle ear abnormalities limit
detectability); hence, the interest in the use of OAEs as an indicator
of hearing status.  Preliminary studies have demonstrated the
feasibility of such an application; however, controlled
large-population studies of normal and at-risk infants, validated by
longitudinal audiologic follow-up, have not been conducted nor have
optimum stimulus and recording parameters been established.  In
addition, general developmental influences and the effects of medical
and pharmacologic factors on OAEs are largely undefined.  The
widespread implementation of OAEs as a general screening device must
await answers to these issues.  In this way, the sensitivity,
specificity, predictive efficiency, and cost effectiveness of an
OAE-based neonatal screening program can be compared to that of ABR
which, despite its various limitations, currently represents the
standard of care.

Goals and Scope

The goal of this RFA is to support the conduct of coordinated
multicenter studies (consortium arrangements), leading to the
development of a system for the identification of neonatal hearing
impairment.  Areas of research appropriate to the RFA may include, but
are not limited to:  screening normal and at-risk neonates with both
ABR and OAE recordings; determining optimum stimulus and recording
parameters for OAE; assessing the influence of co-existing medical
factors on characteristics of ABR and OAE; assessing development-
related changes in OAEs that may occur particularly during the first
year, establishing monaural threshold sensitivity for pure tones and
speech, evaluating sensitivity, specificity, and predictive efficiency
of ABR and OAE test methods, singly and in combination; and evaluation
of time and cost-efficiency of the procedures.  The goals of this RFA
can be met by including the above areas of research in an application
encompassing three project phases:  screening, follow-up, and data
analysis.  A pilot or start-up phase of up to four months may also be
included.  Emphasis should be placed on the existing and potential
strengths of the applicant organizations related to the fulfillment and
completion of the objectives of the RFA.  Appropriate areas may
include, but are not limited to:  arrangements for biostatistical
and/or epidemiologic support; collaborations for ensuring availability
of patients; arrangements for patient accrual; arrangements for
coordination among the cooperating institutions; identification of
essential personnel for recruitment; and development of plans for
acquiring or providing any special research skills needed.

Members of the consortium are expected to participate in all phases of
the project and to include with the application, the experimental
protocol, data collection form, consent form, human subjects approval,
and specific plans for statistical analysis.  The consortium is
expected to obtain an appropriate number of subjects for inclusion in
this project.  Applicant groups are expected to provide both the
equipment and staff needed to accomplish all testing required by the
protocol.  The institutional costs of testing the hearing of infants
usually may not be recovered from the grant.  Under certain
circumstances, at the discretion of the applicant and in order to
ensure the active participation of the institution, the costs of
testing infants entered into the high-risk registry may be recovered.
In that case, the projected direct costs to the grant must be included
in the budget.

Other questions that may be addressed by these studies include, but are
not limited to:

o  To what extent does the presence of middle ear abnormality influence
test results?

o  Do pharmacologic agents administered during the perinatal period
introduce confounding effects on measurement accuracy or reliability?

Applicants should include, in the budget request, provision for an
annual trip to the Washington, DC, area to report progress to NIDCD
staff.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements are required to include
minorities and women in study populations so that research findings can
be of benefit to all persons at risk of the disease, disorder or
condition under study; special emphasis must be placed on the need for
inclusion of minorities and women in studies of diseases, disorders and
conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale must be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research design
and sample size appropriate for the scientific objectives of the study.
This information must be included in the form PHS 398 in Sections 1-4
of the Research Plan AND summarized in Section 5, Human Subjects.
Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However, NIH
recognizes that it may not be feasible or appropriate in all research
projects to include representation of the full array of United States
racial/ethnic minority populations (i.e., Native Americans [including
American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks,
Hispanics).  The rationale for studies on single minority population
groups should be provided.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology, prevention
(and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific questions(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and reflected in
assigning the priority score to the application.

All applications for clinical research submitted to NIH are required to
address these policies.  NIH funding components will not award grants
or cooperative agreements that do not comply with these policies.

REVIEW CONSIDERATIONS

Applications will be evaluated by NIDCD program staff to determine
responsiveness to the RFA.  Responsive applications will then be
evaluated for scientific and technical merit by a review committee
convened by the Scientific Review Branch of the NIDCD solely for this
purpose.  A second level review will be conducted by the National
Deafness and Other Communication Disorders Advisory Council.
Applications that are judged non-responsive will be administratively
withdrawn, and the applicant Principal Investigator and institutional
business official will be notified.  Should an application be judged
non-responsive to this RFA, any of its constituent projects may be
submitted as an investigator-initiated individual research grant (R01)
at the next receipt date or later.  The new application would not be
considered a response to an RFA.

Factors considered to be important for review include demonstrated
expertise in pediatric audiology, identification audiometry,
neonatology, biostatistics and physiologic methods of hearing
assessment; documentation of availability of an appropriate patient
population; documented plans for interaction among collaborating
institutions and clinicians; administrative support by the hospitals,
clinics, or medical centers for all phases of the studies; and adequate
facilities and ancillary personnel.

Reviewers will review the grant applications by considering the
following criteria:

o  Appropriateness, originality, feasibility, and relevance of the
proposed project to the overall goals and objectives of the RFA.

o  Qualifications, experience, and proposed responsibilities of the
Principal Investigators and key personnel.

o  Scientific merit and organizational plans for implementing the
proposed program.

o  Demonstration of availability of normal and at-risk patient
populations.

o  Proposed collaborations among audiologists, otolaryngologists,
neonatologists, nursing staff, and other key personnel within the
applicant and collaborating institutions; adequacy of documented
interest, capabilities, and commitment of all potential participating
clinics.

o  Facilities and resources, and the availability of such for this
project.

o  Adequacy of proposed overall administrative procedures and inter-
and intra-institutional collaborative arrangements.

o  Reasonableness and appropriate justification of the proposed budget.

o  Plans to protect the rights and welfare of human subjects, including
appropriate informed consent procedures.

APPLICATION PROCEDURES

Applications are to be submitted on form PHS 398 (rev. 9/91) using the
instructions included in the application kit.  These kits are available
from the NIDCD Program Administrator cited below and from the Division
of Research Grants, National Institutes of Health, Westwood Building,
Room 449, Bethesda, MD 20892, telephone 301/496-7441.  On page 1 of
form PHS 398, check "yes" in item 2a and type: RFA DC-92-01:
Development of a Model System for the Identification of Neonatal
Hearing Impairment.

The RFA label available in the application form PHS 398 must be affixed
to the bottom of the face page.  Failure to use this label could result
in delayed processing of the application such that it may not reach the
review committee in time for review.

Complete applications are due no later than August 21, 1992, and must
address all requirements in the RFA.  Applications received after this
date will be returned to the applicant without review.  Also, the
Division of Research Grants will not accept any application in response
to this RFA that is the same as one being considered by any other
review group or other NIH awarding unit.  If the application submitted
in response to this RFA is substantially similar to a grant application
already submitted to the NIH for review, but has not yet been reviewed,
the applicant will be asked to withdraw either the pending application
or the new one.  Simultaneous submission of identical applications will
not be allowed, nor will essentially identical applications be reviewed
by different review committees.  Therefore, an application cannot be
submitted in response to this RFA that is essentially identical to one
that has already been reviewed.  This does not preclude the submission
of substantial revisions of applications already reviewed, but such
applications must include an introduction addressing the previous
critique.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research.  In such a case, a letter of agreement from either the GCRC
program director or Principal Investigator must be included with the
application.

Submit a signed, typewritten original of the application, including the
Checklist, and four signed photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

The photocopies must be clear and single sided.  To facilitate a timely
review, send one additional copy of the application and any appendix
material, under separate cover to:

Dr. Earleen Elkins
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
Suite 400-B, Executive Plaza South
6120 Executive Boulevard
Rockville, MD  20852

LETTER OF INTENT

Prospective applicants are asked to submit, by July 31, 1992, a letter
of intent that includes a descriptive title of the proposed project,
the name and address of the Principal Investigator, the names of other
key personnel and collaborating institutions, and the number and title
of the RFA in response to which the application is being submitted.
Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, submission of
such a document allows NIDCD review staff to estimate the review
workload and avoid conflict of interest in the review.

The letter of intent is to be sent to:

Amy Donahue, Ph.D.
Chief, Hearing Program
Division of Communication Sciences and Disorders
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Suite 400B
6120 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 402-3458
FAX:  (301) 402-6251

AWARD CRITERIA

The anticipated date of award is April 1, 1993.

In addition to technical merit, award decisions will be based on the
responsiveness to the RFA, the availability of resources, and the
composition of the study populations.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.  Direct inquiries regarding programmatic issues
to:

Amy Donahue, Ph.D.
Chief, Hearing Program
Division of Communication Sciences and Disorders
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Suite 400-B
6120 Executive Boulevard
Rockville, MD  20852
Telephone:  (301) 496-5061
FAX:  (301) 402-6251

Direct inquiries regarding fiscal matters and requirements for the
formation of consortia to:

Sharon Hunt
Division of Extramural Activities
Grants Management Branch
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Suite 400-B
6120 Executive Boulevard
Rockville, MD  20852
Telephone:  (301) 402-0909

AUTHORITY AND REGULATIONS

The NIDCD program is described in the Catalog of Federal Domestic
Assistance No. 93.173.  Awards will be made under the authority of the
Public Health Service Act, Section 301 (Public Law 78-410, as amended;
42 USC 241) and administered under PHS Grant Policy Statement and
Federal Regulations 42 CFR Part 52 and 45 CFR Part 74 or 92.  The
program is not subject to review by a Health Systems Agency or to the
intergovernmental review requirements of Executive Order 12372.

.

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